LEVOFLOXACIN | N020635 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizens Petition from Baxter Healthcare Corporation FDA-2016-P-1547 · 5 docket documents Baxter Healthcare Corporation filed this Section 505(j) citizen petition requesting that the FDA amend the Orange Book to designate Levofloxacin in Dextrose 5% in Plastic Container (ANDA A090343, held by ACS Dobfar) as a second reference listed drug for Levofloxacin injection in 5% dextrose, replaci | Other | 2016-06-14 | Granted | Baxter Healthcare Corporation |
Office of Illinois Attorney General FDA-2005-P-0064 · 6 docket documents The Office of the Illinois Attorney General, filed this citizen petition on May 18, 2005, requesting that the FDA require manufacturers of fluoroquinolone antibiotics (ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin) to strengthen labeling warnings about tendonopathy and tendo | Other | 2005-05-24 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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